Florida Certified Designated Representative (CDR) Application Available Online

Vitamin bottles and pillsHere’s how to find the FL CDR application form online.

Go to the following webpage:
Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics – Certified Designated Representative

Then scroll down to the bottom of the page, and click on:
Apply Using A Printable Application

If you need help, the page states:
If you have any questions or need assistance completing these forms, please call the Drugs, Devices and Cosmetics Program at (850) 717-1800.


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Florida Certified Designated Representative (CDR) Required For Wholesale Distributors

Law books, gavel, scaleThe Florida Department of Business & Professional Regulation – Division of Drugs, Devices and Cosmetics answers the question, “Does my company need a permit?”  Their answer includes a helpful chart, definitions, and a link to relevant Florida statutes

Prescription drug wholesalers need to have a Florida Certified Designated Representative (CDR):

“CERTIFIED DESIGNATED REPRESENTATIVE

All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”).”

Source: Certified Designated Representative – Florida Department of Business & Professional Regulation


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FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

FDA letters on building blocks

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””

Read the full article: Source: FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review


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NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors – Drug Channels

Graphic of different kinds of medicines

“This year’s report—our sixth edition—has been updated, revised, reorganized, and expanded. It contains the latest industry and financial data, along with detailed information about the strategies and market positions of the largest public companies: AmerisourceBergen, McKesson, and Cardinal Health. It also includes many new elements.”

Read the full article: Source: Drug Channels: NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors


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Who Offers Designated Representative Training Courses?

Stethoscope on keyboard with a gavelSkillsPlus International Inc. offers California Designated Representative training courses (approved by the California State Board of Pharmacy). They’re very popular for their convenience, and availability 24 hours a day & 7 days a week!

Learn more: Designated Representative training & Exemptee training taught by SkillsPlus International Inc.

#designated #representative #training #exemptee #3PL #pharmacy #HMDR


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FDA Recommends New Testing Standards for Home Use Devices | RAPS

FDA Logo for the CDRH“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.

Background

In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.

The latter category, often referred to as “home use devices,” is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.”

Read the full article: via FDA Recommends New Testing Standards for Home Use Devices | RAPS.

Read the final FDA guidance:
Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF)


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Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce

Assorted drug capsules and tabletsHDMA’s 2014-15 Factbook updates member financial, operational performance.

The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”

Learn more details, read the full article: via Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce.


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It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!

Prepping vegetables in the kitchenThe holidays are coming!

Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December.

Just get it done now, before:

  • the kids get out of school
  • you find yourself cooking in the kitchen
  • shopping for the holidays

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Industry groups take issue with guidance on outsourcing facilities

FDA Inspection - Magnifying glass over FDA investigator badge“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.”

Similarly, BIO disagrees with FDA’s proposed alternative approaches for reducing the need for laboratory testing of incoming components and to minimize the need for facilities to have an in-house laboratory.

“We believe that the alternative approach to testing should not be permitted exclusively for outsourcing facilities,” BIO says. “These sites should be accountable for maintaining the same level of control over their contract sites as would any other pharmaceutical manufacturer.””

Read the full article: via Industry groups take issue with guidance on outsourcing facilities.


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HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

President Obama signing new law“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S.

The law will transform how the domestic supply chain operates to the benefit of healthcare providers and pharmacists — and their patients. HDMA and the nation’s primary pharmaceutical distributors have long advocated for this national solution.

With enactment of the law:

All existing state pedigree requirements that went above and beyond the Prescription Drug Marketing Act (PDMA) of 1987 are immediately preempted. The baseline requirements of the original law will remain in place until January 1, 2015, when statutory requirements, assisted by guidances currently being developed by FDA, will go into effect.

In 2015, enhanced product tracing requirements begin, which over 10 years, will lead to the establishment of a single system of federal electronic, unit-level traceability requirements across the entire supply chain.

National distributor licensure standards also have been strengthened. Instituting strong, consistent distributor licensing standards is a critical component in ensuring that the supply chain remains safe and secure.”

Read the full article, and reference a great collection of fact sheets and educational material about this subject: via HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act.


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